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Completed

NCT Number: NCT00349037

Study of the Ability of a Flu Vaccine to Prevent Flu Infection

The purpose of this study is to evaluate how effective the vaccine is at preventing subjects developing flu symptoms after they are directly exposed to flu virus. The study will also evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GDRU Quintiles Ltd

London, United Kingdom

About this study

Influenza is a contagious disease of the upper airways and the lungs. It rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity. Each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination. Current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all. This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for influenza as a potential alternative to existing vaccine technologies. This study will assess how effective two different PMED vaccine combinations are at preventing subjects developing influenza following exposure to flu virus 56 days after a single dose of vaccine.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy adult volunteers (women must be of non child-bearing potential)

Provided written informed consent

Exclusion criteria

No significant concomitant illness

No allergy to gold

No immunosuppression due to disease or treatment

Pre-existing protective level of antibody against the challenge virus strain

Treatment and study plan

Trivalent DNA vaccine with and without pPJV2012 administered by PMED

Biological

Primary outcomes

  1. Efficacy of the vaccine in preventing symptoms of influenza-like illness

Secondary outcomes

  1. Safety and tolerability - AEs and laboratory tests. Immunogenicity of the vaccine

Sponsors and collaborators

Lead sponsor

PowderMed

Industry

Registry information

Official study title

A Prospective, Randomised, Double Blind, Placebo-Controlled Study to Assess the Efficacy of a Trivalent (A/New Caledonia/20/99, A/Panama/2007/99, B/Jiangsu/10/20) DNA Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) Against a Controlled Influenza Virus Challenge.

Important dates

Study start
2006
Study completion
2007
First posted
Jul 6, 2006
Registry last updated
Jan 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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